Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: To assess efficacy and safety of SC golimumab (GLM) in polyarticular pediatric juvenile idiopathic arthritis pts (aged 2 to <18 yrs) with active arthritis despite MTX for ≥3months.
Methods: In GO-KIDS, a 3-part randomized double-blind, PBO-controlled, withdrawal trial in pts with active JIA with a polyarticular course (≥5 active joints) and disease duration of ≥ 6 months despite current MTX (10-30 mg/m2/wk).In Part 1(wk0-12), all pts received open-label (OL) 30 mg/m2 GLM SC(max 50mg) q4wks with stable MTX dose. At wk16, pts with ACR JIA 30 response entered Part 2 (wk16-48).In Part 2, pts were randomized to continue GLM or switch to PBO q4wks. Upon Part 2 completion at wk48 or ACR JIA flare in Part 2, pts received OL GLM in Part 3. Primary endpoint was proportion of ACR JIA 30 responders at wk16 without a JIA flare in Part 2 using wk16 as baseline measurement. Secondary outcomes were ACR JIA 30/50/70/90 response rates and inactive disease rates at wk16 and wk48 by group and safety.
Results: 173 pts (Caucasian 87.9%, 75.7% females; age [median/range] 12 yrs/2-17 yrs) with moderately active disease were enrolled (Table1); 19 (11%) were d/c in Part 1 (lack of efficacy n=14, AE n=4, withdrawal of consent n=1). In Part 1, 151 of 173 (87.3%) achieved an ACR JIA 30 response and 36.1% inactive disease status (Table2). In Part 2, 154 pts were randomized (PBO n=76; continued GLM n=78). The trial did not meet primary endpoint, as at the end of Part 2 groups did not differ in flare rates [PBO-grp vs. GLM-grp: 52.6% vs. 59.0%, p=0.41) nor were there differences for major secondary endpoints (Table2).Nonetheless, sustained JIA improvement was maintained in both groups (PBO, GLM) relative to wk 0 (Table1 and 2). Through wk48, AEs, serious AE (SAE), and serious infections were reported in 87.9%, 13.3%, and 2.9% of all randomized pts, respectively. Most common SAE was JIA exacerbation. No deaths, active TB or malignancies were reported. Proportion of pts with ≥ 1 injection site reaction was 8.1%. None of the reactions were serious, severe, or led to GLM d/c.
Conclusion: Children with active polyarticular JIA demonstrated rapid response to GLM during16 wks of OL treatment, resulting in inactive disease in 36% of the pts after 3 injections of OL GLM during part 1. The lack of differences in flare rates between GLM and PBO arms during the double-blinded part of the study among OL GLM responders needs further evaluation. Safety profile was acceptable and injections well tolerated.
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Table 1 |
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Values are medians (interquartile range) |
At Baseline (All enrolled patients n=173) |
At wk16 (All randomized patients prior to randomization, n=154) |
At wk48 |
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PBO + MTX (n=76) |
GLM + MTX (n=78) |
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Physicians global assessment of disease activity |
5.40 (3.90; 7.00) |
0.50 (0.10; 1.30) |
0.30 (0.00; 1.00) |
0.30 (0.00; 1.30) |
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Patient/parent global assessment of well-being |
4.50 (2.80; 6.10) |
0.90 (0.30, 2.30) |
0.60 (0.20; 1.65) |
0.45 (0.10; 1.70) |
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Number of active joints |
12.0 (8.0; 18.0) |
1.0 (0.0; 3.0) |
1.0 (0.0; 3.0) |
0.0 (0.0; 2.0) |
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Number of joints with limited range of motion |
8.0 (6.0; 15.0) |
1.0 (0.0, 4.0) |
0.5 (0.00; 4.0) |
1.0 (0.0; 3.0) |
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Physical function by CHAQ |
0.94 (0.38; 1.50) |
0.25 (0.00; 0.75) |
0.13 (0.00; 0.63) |
0.00 (0.00; 0.63) |
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ESR (mm/hr) |
16.00 (8.00; 28.00) |
9.00 (5.00; 19.00) |
9.50 (5.00; 16.50) |
10.00 (5.00; 19.00) |
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Methotrexate (mg/wk) |
15 (5.00; 30.00) |
15 (5.00; 30.00) |
15 (5.00; 30.00) |
15 (5.00; 30.00) |
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Table 2: ACR JIA response and flare rates |
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PART 1 [WK 0 -16] |
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Percentage of ACR JIA responders at end of Part 1 [WK 16] (n =173) |
JIA ACR 30 |
87.3% (151) |
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JIA ACR 50 |
79.2% (137) |
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JIA ACR 70 |
65.9% (114) |
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JIA ACR 90 |
36.4% (63) |
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Inactive disease |
36.1% (62) |
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PART 2 [WK 16- 48] |
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Percentage of ACR JIA 30 responders without flare in Part 2 (n = 154) |
PBO + MTX (n=76) |
52.6% (40) |
P=0.41 |
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GLM + MTX (n=78) |
59.0% (46) |
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Percentage of ACR JIA responders at WK48 (vs. wk0) by treatment in Part 2* [PBO +MTX /GLM +MTX] |
JIA ACR 30 |
95.9% / 89.0% |
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JIA ACR 50 |
91.8% / 86.3% |
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JIA ACR 70 |
78.1% / 78.1% |
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JIA ACR 90 |
53.4% / 56.2% |
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Inactive disease [PBO +MTX /GLM +MTX] |
PBO + MTX (n=76) |
27.6% (21) |
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GLM + MTX (n=78) |
39.7% (31) |
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Clinical remission [PBO +MTX /GLM +MTX] |
PBO + MTX (n=76) |
11.8% (9) |
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GLM + MTX (n=78) |
12.8% (10) |
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Pts experiencing flares/those considered treatment failures due to protocol violations are considered ACR non-responders from the flare failure visit to wk48 *Observed data |
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Disclosure:
H. I. Brunner,
Janssen R and D, LLC,
2;
N. Ruperto,
Janssen R and D, LLC,
2;
N. Tzaribachev,
Janssen R and D, LLC,
2;
G. Horneff,
Janssen R and D, LLC,
2;
C. Wouters,
Janssen R and D, LLC,
2;
V. V. Panaviene,
Janssen R and D, LLC,
2;
V. Chasnyk,
Janssen R and D, LLC,
2;
C. Abud-Mendoza,
Janssen R and D, LLC,
2;
R. Cuttica,
Janssen R and D, LLC,
2;
A. Reiff,
Janssen R and D, LLC,
2;
M. Maldonado-Velázquez,
Janssen R and D, LLC,
2;
N. Rubio-Pérez,
Janssen R and D, LLC,
2;
R. Joos,
Janssen R and D, LLC,
2;
V. Keltsev,
Janssen R and D, LLC,
2;
E. Nasonov,
Janssen R and D, LLC,
2;
D. Kingsbury,
Janssen R and D, LLC,
2;
M. Bandeira,
Janssen R and D, LLC,
2;
E. Silverman,
Janssen R and D, LLC,
2;
F. Weller-Heinemann,
Janssen R and D, LLC,
2;
A. van Royen-Kerkhof,
Janssen R and D, LLC,
2;
A. M. Mendelsohn,
Janssen R and D, LLC,
2;
L. Kim,
Janssen Research & Development, LLC.,
3;
D. Lovell,
Janssen R and D, LLC,
2;
A. Martini,
Janssen R and D, LLC,
2.
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